JPRN-UMIN000002518已完成1 期
Hybrid biotherapy involving autologous human cardiac stem cell transplantation combined with the controlled release of bFGF using a gelatin hydrogel sheet to treat severe refractory heart failure with chronic ischemic cardiomyopathy - AutoLogous human CArdiac-Derived stem cell to treat Ischemic cArdiomyopathy (ALCADIA)
Kyoto Prefectural University School of Medicine0 个研究点目标入组 6 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1)New onset of myocardial infarction or unstable angina within 28 days prior to study entry 2)Indication for surgical ventricular reconstruction or mitral valve repair *1 3)Contraindication for endomyocardial biopsy *2 4)Evidence for malignant disease within 3 years prior to study entry 5)Chronic hemodialysis 6)Liver Cirrhosis (ICGR 15>30%) 7)Uncontrollable diabetes mellitus (HbA1c>8.0) 8)Maximum diameter of Aortic aneurysm more than 5cm(including dissecting aneurysm) 9)Cardiogenic shock 10)Active infection (including cytomegalovirus infection) 11)Drug or alcoholic dependency 12)Positive for HIV antigen 13)Active bleeding state (gastric ulcer, cerebral bleeding, etc.) 14)Gelatin allergy *3 15)Chromosomal abnormality *1an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area *2contra-indication for endomyocardial biopsy 1 cardiogenic shock 2 end-stage or uncontrollable congestive heart failure without continues infusion of catecholamine 3 complete or mobitz type AV block *3The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-IgE
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